NCT07288203进行中（未招募）2 期
A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma
详细描述
This is a Phase 2 study of the lifileucel treatment regimen in participants who previously received treatment for unresectable or metastatic (advanced) melanoma with 1 prior line of an anti-programmed cell death protein-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agent or whose melanoma progressed during and/or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (early relapse). Participants who have BRAF V600 mutation positive melanoma may have received or refused 1 additional prior line treatment with a BRAF inhibitor
± a MEK inhibitor
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- •The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months.
- •The participant must have experienced radiographic disease progression on: 1 prior line of an anti-PD-(L)1 treatment (as a monotherapy or as part of a combination) for advanced melanoma and/or during or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (as a monotherapy or as part of a combination). Participants who have BRAF V600 mutation positive melanoma may have received 1 additional prior line of treatment with a BRAF inhibitor ± a MEK inhibitor.
- •Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
- •Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
- •Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
- •Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- •Participants must have adequate organ function.
- •Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.
排除标准
- •Participant has melanoma of uveal/ocular origin.
- •Participant has symptomatic untreated brain metastases.
- •Participant has active uveitis that requires active treatment.
- •Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- •Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- •Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated >1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
- •Participant has a history of allogeneic cell or organ transplant.
- •Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Single Arm
Experimental
Lifileucel
干预措施: Lifileucel (Biological)
结局指标
主要结局
Objective Response Rate
时间窗: 5 years
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
次要结局
- Complete Response Rate(5 years)
- Duration of Response(5 years)
- Disease Control Rate(5 years)
- Progression-Free Survival(5 years)
- Objective Response Rate(5 years)
- Overall Survival(5 years)
- Adverse Events(5 years)
研究者
研究点 (9)
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